Back to Search Start Over

A research agenda for moving early medical pregnancy termination over the counter

Authors :
Laura Castleman
Nathalie Kapp
Dalia Brahmi
Daniel Grossman
Emily Jackson
Source :
Bjog
Publication Year :
2017
Publisher :
John Wiley and Sons Inc., 2017.

Abstract

Given the overall safety profile and increasing availability of medical pregnancy termination drugs, we asked: would the mifepristone–misoprostol regimen for medical termination at ≤10 weeks of gestation meet US Food and Drug Administration regulatory criteria for over‐the‐counter (OTC) approval, and if not, what are the present research gaps? We conducted a literature review of consumer behaviours necessary for a successful OTC application for medical termination at ≤10 weeks of gestation and identified crucial research gaps. If we were to embark on a development programme for OTC or more generally, self‐use of medical termination, the critical elements missing are the label comprehension, self‐selection and actual use studies. Tweetable abstract Considering medical pregnancy termination through the over‐the‐counter regulatory lens clarifies critical evidence gaps.<br />Tweetable abstract Considering medical pregnancy termination through the over‐the‐counter regulatory lens clarifies critical evidence gaps.

Details

Language :
English
ISSN :
14710528 and 14700328
Volume :
124
Issue :
11
Database :
OpenAIRE
Journal :
Bjog
Accession number :
edsair.doi.dedup.....abd8f80d5fd536da9e6430642dd07e26